IA #36-04, 12/10/08, IMPORT ALERT #36-04, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF HONEY AND BLENDED SYRUP DUE TO PRESENCE OF
***FLUOROQUINOLONES***" " ATTACHMENT A 3/10/09
NOTE: The revision of this import alert dated 12/10/2008 changes the
name of the import alert and amends the scope of the alert to include
all forms of fluoroquinolone antibiotics. Changes are bracketed by
asterisks (***).
NOTE: The revision of this import alert dated 12/28/2007 changed the
name of the import alert, updated the product codes, and amended the
text to reflect blended syrups as products of concern.
TYPE OF ALERT: Detention Without Physical Examination
(Note: This import alert contains guidance to FDA field personnel only.
It does not establish any requirements, or create any rights or
obligations on FDA or on regulated entities).
PRODUCT: All honey products (comb honey, strained honey, whipped
honey, honey)
Blended Syrups
PRODUCT
CODE : 36C[][][]
36B[][]10
PROBLEM: Fluoroquinolone residues
PAC: FAD (Food Additives)
ANT (Drug Residues)
PAF: 04F800
09006A
COUNTRY: See attachment
MANUFACTURER/
SHIPPER: See attachment
MANUFACTURER/
SHIPPER ID#: N/A
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to bear or contain a
food additive, namely, fluoroquinolone(s), that is unsafe
within the meaning of Section 409 [Adulteration, Section
402(a)(2)(C)(i)"; Charge Code = UNSAFE ADD]
OR
"The article is subject to refusal of admission pursuant to
Section 8Ol(a)(3) in that it appears to be adulterated in
that it bears or contains a new animal drug (or conversion
product thereof) that is unsafe within the meaning of
section 512 [Adulteration, 402(a)(2)( C ) [ii)"; Charge code
= VETDRUGS]
RECOMMENDING
OFFICES: CFSAN, OC, DE, Imports Branch (HFS-606)
ORA, ORO, DIOP (HFC-170)
REASON FOR
ALERT: Fluoroquinolone antibiotics, including ciprofloxacin and
enrofloxacin, have been used in the treatment of diseases.
Enrofloxacin is approved for use in cattle (21 CFR 522.812)
but there are no other approvals for use in other food
animals. The use of fluoroquinolones in honey bees or their
environment can result in residues in honey.
Fluoroquinolones are not generally recognized as safe to
treat any honey bee diseases nor are they approved for such
use. In addition, fluoroquinolones have been prohibited from
extra label use in food producing animals as per 21 CFR
530.41 because of concerns about the threat to public
health. Fluoroquinolones used to treat any honey bee disease
is considered to be an unapproved new animal drug use within
the meaning of Section 512.
Furthermore, fluoroquinolones are not generally recognized
as safe for any use in a manner that could reasonably be
expected to result in their becoming a component of honey
nor are they approved for this use. Therefore,
fluoroquinolones in honey are considered to be unsafe food
additives within the meaning of Section 409 of the Food,
Drug, and Cosmetic Act.
In February 2006, the Florida Department of Agriculture and
Consumer Services (FDACS) became aware of a problem
concerning adulteration of honey with fluoroquinolones.
FDACS collected and analyzed samples of honey for residues
of two of the fluoroquinolones of concern, ciprofloxacin and
enrofloxacin. The state reported that residues of these
antibiotics were found in honey that was traced back to a
firm from the People's Republic of China.
Because of concerns about the presence of fluoroquinolones
in the food supply, the U.S. is continuing to develop
methods and strategies to detect illegal residues and
prevent their introduction into the U.S. food supply.
In 2007, two shipments of products declared and labeled as
"blended syrups" were analyzed and found to contain
ciprofloxacin. For that reason, in December, 2007, blended
syrups were added to this import alert as a product of
concern.
GUIDANCE: Districts may detain without physical examination (DWPE) all
shipments of honey, honey products and blended syrups from
the firms listed in the attachment of this Import Alert.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
827-7605.
PRIORITIZATION
GUIDANCE: I
FOI: No Purging Required
KEYWORDS: Honey, Antibiotics, Animal drugs, Food additive,
Fluoroquinolones, Ciprofloxacin, Enrofloxacin,
Blended Syrup, ***Norfloxacin***
PREPARED BY: Ted Poplawski, DIOP (301) 594-3849
Julie Mayer, CFSAN, OC, DE, Imports
REVISED BY: Judy Baron, DIOP, 12/8/08
Nawab Siddiqui, DIOP, 12/28/07
DATE LOADED
INTO FIARS: December 10, 2008
Attachment A 3/10/09
Firms Recommended for DWPE
China (CN)
Firm Name: Residue: *** Product/
Product code ***
Hubei Yusun Co., Ltd. Ciprofloxacin Blended syrup
168 Jingwu, Hankou 36B[][]10
Wuhan 1/4/08
China
FEI# 3005404645
Inner Mongolia Altin Bee-Keeping Co.,Ciprofloxacin *** Honey ***
Ltd. Jinshan Development Area ***6C[][][][] ***
Hohhot, China 11/3/2006
FEI# 3005402797
Jiangsu Kanghong Natural Health Ciprofloxacin *** Honey ***
Foods Co., Ltd *** 36C[][][][] ***
Tngyu North Road, Funing County 11/3/2006
Yancheng, China
FEI# 3004299426
Shanghai Talside Trading Co., Ltd. Ciprofloxacin *** Honey ***
216 Lane 1735 Zhen Nan Rd. *** 36C[][][][] ***
Shanghai, China 11/3/2006
FEI# 3005132954
Shunchang Industry Co., Ltd Ciprofloxacin Blended Syrup
Jingmen Hi Tech Industrial 36B[][]10
Development Z 36B[][]10
Hubei, Jingmen City 2/12/08
China (Mainland)
FEI # 3006378204
Wuhan Jiabao Syrup Factory Norfloxacin Honey Syrup
515 Luoshi Road 12/10/08 36B[][]10
Hongshan District 36B[][]99
Wuhan
Hubei, China
FEI# 2000040803
Wuhan Shino-Foods Trade CO., Ltd. Ciprofloxacin *** Honey ***
515 Luoshi Avenue, Hongshan *** 36C[][][][] ***
Wuhan, China 11/3/2006
FEI# 3005109776
MONGOLIA (MN)
FIRM NAME & ADDRESSS RESIDUE PRODUCT/CODE
Inner Mongolia Youth Norfloxacin Honey
Trade Development 36C[][][]
No. 47 Xinching Xijie Hotel 1/5/09
Floor 3
Xincheng District
Hohhot, Mongolia
FEI# 3006299696
THAILAND (TH)
Firm Name: Residue: Product/
Product Code
Tha Yu Inter Trading Co.,LTD. Ciprofloxacin Honey
3/6 MOO 11 Kwang Sikan Khet 3/10/09 36C[][][][]
Donmuang, Bangkok, Thailand
FEI# 2000023125
VIETNAM (VN)
FIRM NAME AND ADDRESS RESIDUE PRODUCT/CODE
Chaochin Industrial Co., Ltd. Norfloxacin Honey
Industrial Service Zone (Fluoroquinolone 36C[][][][]
National Highway 15 family)
Long Binh Ward 9/4/08
Bien Hoa City, Dong Nai
Vietnam
FEI # 2000009921
|
